Follicular lymphoma Follicular lymphoma
Conditions
Interventions
Treatment consists of 6 x 28 day cycles of obinutuzumab and bendamustine as follows:
- Obinutuzumab is administered at a dose of 1000mg on Day 1, 8 and Day 15 of the first 28 day treatment cycle. For
Sponsors
Honda Akira
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically diagnosed with CD20-positive follicular lymphoma (except for grade 3b) 2. Without having received chemotherapy, molecular targeted therapy, or radiation therapy for follicular lymphoma 3. Aged 70 years and above at the time of informed consent 4. Male or female 5. Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation 6. Able to attend all scheduled visits
Exclusion criteria
Exclusion criteria: 1. With severe liver failure, renal failure, or cardiac disease (judged by CTCAE v5.0-JCOG grade 3) 2. Having received systemic chemotherapy for malignancy except for follicular lymphoma in 4 weeks before informed consent 3. With uncontrolled cancer except for follicular lymphoma 4. With a history of allergy to components of bendamustine or obinutuzumab 5. With a history of severe drug allergy including anaphylactic shock, or a history of severe side effects 6. Having taken study drugs in other clinical trials in 4 weeks before informed consent 7. Scheduled to receive chemotherapy or radiation therapy between the informed consent and the end of this trial 8. Judged as ineligible by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety (incidence of adverse events of grade 3 or more) 2. Progression free survival and overall survival 3. Progression of disease within 24 months | — |
Contacts
Public ContactAkira Honda
The University of Tokyo Hospital
Outcome results
None listed